CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 30 enrolled
Drug / intervention
Pembrolizumab Injectiondrug
Likely dose
Pembrolizumab Injection 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04808999
NCT04808999Phase 2Active

Phase II Neoadjuvant Study of PD-1 Inhibitor Pembrolizumab in PD-1 Naive Cutaneous Squamous Cell Carcinoma (cSCC)

Diwakar Davar·interventional·Posted Mar 22, 2021·Updated May 29, 2025

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab Injection for Squamous Cell Carcinoma. Active but no longer recruiting, targeting 30 participants across 1 site.

Detailed Summary

This phase II single-arm two-stage neoadjuvant study of pembrolizumab in patients with PD-1 naïve high-risk resectable cutaneous squamous cell carcinoma (cSCC) will be conducted over a 52-week period. The study will include patients who have not undergone surgery to remove disease, to formally evaluate whether both biologically and clinically high-risk disease may benefit from neoadjuvant anti-PD-1 therapy. Response to neoadjuvant anti-PD-1 therapy will be evaluated for association with improved landmark Relapse-free Survival (RFS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2Active
202120222023202420252026202720282029
First PostedMar 22, 2021
Enrollment StartMay 11, 2021
Primary CompletionApr 12, 2024
Study CompletionApr 30, 2029
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 5.3 years ago

Interventions

Pembrolizumab Injectiondrug

200 mg IV infusion